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Test Code USTEKM Ustekinumab Quantitation with Antibodies, Serum

Additional Codes

Mayo USTEK
Epic ID LAB3362

 

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL Serum

Collection Instructions:

1. Draw blood immediately before the next dose of drug administration (trough level).

2. Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

Serum: 0.35 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 21 days
  Frozen  21 days
UPH Waterloo Region Lab Test Catalog Note:

Transport refrigerated.

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-inactivated specimen Reject

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Profile Information

Test ID Reporting Name Available Separately Always Performed
USQN Ustekinumab QN, S No Yes
USTAB Ustekinumab Ab, S No Yes

Useful For

Evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence (in inflammatory bowel disease) and acute infusion reactions using trough level specimens

 

This test does not differentiate between the originator and biosimilar products.

Day(s) Performed

Monday, Thursday

Report Available

2 to 6 days

Reference Values

USTEKINUMAB QUANTITATION:

Limit of quantitation is 0.3 mcg/mL

 

For maintenance stages:

Concentrations ≥1.0 mcg/mL are associated with clinical response and clinical remission

Concentrations ≥4.5 mcg/mL are associated with mucosal healing

 

USTEKINUMAB ANTIBODIES:

Limit of quantitation is 10 AU/mL

Absent: <10 AU/mL

Present: ≥10 AU/mL

CPT Code Information

80299

83520